Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

The Primary Endpoint of This Study is the Median Time Between Admission to the PICU and Occurrence of Nosocomial Infection or Clinical Sepsis in PICU Patients Who Have Endotracheal Tubes, Central Venous Catheters, or Urinary Catheters. [ Time Frame: 48 hours after admission until 5 days after discharged from the PICU ]

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All randomized patients per intention to treat analysis

Reporting Groups

Description

Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide

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Enteral Whey Protein, IV Saline

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Measured Values

Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide

Enteral Whey Protein, IV Saline

Participants Analyzed [Units: Participants]

149

144

Antibiotic-free Days [Units: Days]Median (Inter-Quartile Range)

1
(0 to 5)

2
(0 to 6)

Statistical Analysis 1 for Antibiotic-free Days

Groups [1]

All groups

Statistical Test Type [2]

Superiority or Other

Statistical Method [3]

Wilcoxon (Mann-Whitney)

P Value [4]

0.09

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

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[2]

Details of power calculation, definition of non-inferiority margin, and other key parameters:

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[3]

Other relevant method information, such as adjustments or degrees of freedom:

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[4]

Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:

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4. Secondary:

Incidence of Prolonged Lymphopenia (Absolute Lymphocyte Count Less Than or Equal to 1,000/mm³ for > or Equal to 7 Days) [ Time Frame: from time of PICU admission till discharge from PICU ]